Stavudine Capsules

Generic name: Stavudine

Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs)

Dosage form: Oral capsule (15 mg; 20 mg; 30 mg; 40 mg)

Root of administration: Oral

Dose:

• Adults weighing less than 60 kg: 30 mg every 12 hours
• Adults weighing at least 60 kg: 40 mg every 12 hours
• Pediatric patients:
  • Newborns from birth to 13 days old: 0.5 mg/kg every 12 hours
  • At least 14 days old and weighing less than 30 kg: 1 mg/kg every 12 hours
  • Weighing at least 30 kg: adult dose

Mechanism of action: Stavudine is a synthetic nucleoside analog that, after phosphorylation to its active triphosphate form, inhibits HIV reverse transcriptase by competing with the natural substrate deoxythymidine triphosphate and by incorporating into viral DNA, causing chain termination due to the lack of a 3′-OH group. This results in the inhibition of viral replication. Stavudine triphosphate also inhibits cellular DNA polymerases beta and gamma, leading to reduced mitochondrial DNA synthesis.

Drug usage cases:

• Approved: Treatment of HIV-1 infection in combination with other antiretroviral agents
• Off-label: Not specified

Drug contraindications:

• Hypersensitivity to stavudine or any component of the formulation
• Coadministration with didanosine or zidovudine

Side effects:

• Common: Headache, diarrhea, peripheral neuropathy (numbness, tingling, or pain in hands or feet), rash, nausea, vomiting
• Serious: Lactic acidosis, hepatotoxicity (including severe hepatomegaly with steatosis), pancreatitis, lipoatrophy, immune reconstitution syndrome

Warnings:

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases
• Pancreatitis, which can be fatal
• Peripheral neuropathy, which can be severe and may require discontinuation of therapy
• Lipoatrophy (localized loss of body fat), which may be irreversible
• Immune reconstitution syndrome, which may occur after initiating antiretroviral therapy
• Use with caution in patients with liver disease, including hepatitis C, and those with a history of pancreatitis
• Not recommended for use in combination with hydroxyurea

Use during pregnancy or breastfeeding: Stavudine has been associated with fatal lactic acidosis in pregnant individuals when used in combination with didanosine. Therefore, coadministration of stavudine with didanosine is contraindicated. Stavudine is not recommended for use during breastfeeding due to the potential for HIV-1 transmission.